A Phase I, Open-Label, Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending Doses of AZD0530 in Combination With Carboplatin and Paclitaxel Chemotherapy in Japanese Patients With Advanced Solid Malignancies
Overview
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- AstraZeneca
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, general examination, HRCT, SpO2, ECG
Overview
Brief Summary
The primary purpose of this study is to explore the safety and tolerability of AZD0530 in combination with carboplatin and paclitaxel in Japanese patients with non small cell lung cancer and epithelial ovarian cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Japanese patients with non small cell lung cancer or epithelial ovarian cancer
- •Must be suitable for treatment with carboplatin and paclitaxel
- •Relatively good overall health other than cancer
Exclusion Criteria
- •Poor bone marrow function (not producing enough blood cells).
- •Poor liver or kidney function.
- •Patients unable to discontinue drugs known to be potent inhibitors or inducers of CYP3A4 within 2 weeks prior to registration
Arms & Interventions
AZD0530 + carboplatin and paclitaxel
AZD0530 in combination with carboplatin and paclitaxel
Intervention: AZD0530 (Drug)
AZD0530 + carboplatin and paclitaxel
AZD0530 in combination with carboplatin and paclitaxel
Intervention: Carboplatin (Drug)
AZD0530 + carboplatin and paclitaxel
AZD0530 in combination with carboplatin and paclitaxel
Intervention: paclitaxel (Drug)
Outcomes
Primary Outcomes
Assessment of adverse events (based on CTCAE version 3.0), laboratory values, vital sign measurements, general examination, HRCT, SpO2, ECG
Time Frame: Laboratory assessment prior to chemotherapy administration in all treatment cycles and on days 2, 8 and 15 in cycle 1. General exam, SpO2 and ECG prior to chemotherapy administration in all treatment cycles. HRCT scans performed days 21, 42, 70-98.
Secondary Outcomes
- Assessment of the pharmacokinetics of AZD0530 (Cssmax, Cssmin, tmax, AUCss0-24, CL/F), its N-desmethyl metabolite M594347 (Cssmax, Cssmin, tmax, AUCss0-24), and carboplatin / paclitaxel (Cmax, AUC, AUC0-t, t1/2, CL and Vss)(Schedule of PK assessment1. AZD0530/N-desmethyl metabolite M594347Cycle1-day21 -Cycle2-day2; 11point2. carboplatinCycle1-day1 ~ day2; 8 pointCycle2-day1 ~ day2; 8 point3. paclitaxelCycle1-day1 ~day2; 9 pointCycle2-day1 ~ day2; 9 point)